Quality Control Supervisor: CAPA & Compliance

Terumo Cardiovascular Group; Florida; On-site; USD 72,000 - 100,000; Full time

Job summary

Terumo Aortic is seeking a Quality Operations supervisor to lead inspectors, analyze NCRs, and ensure compliance with ISO 13485 and 21 CFR 820. The role involves coordinating audits, driving process improvements, and collaborating with R&D to implement corrective actions.

The position demands a BS in Engineering or equivalent medical device quality experience, strong analytical abilities, and the ability to motivate teams while improving efficiency.

Qualifications

• BS in Engineering or 5+ years in Medical Device quality.
• Familiarity with management of non-conforming product.
• Familiarity with sampling plans and failure analysis investigations.

Responsibilities

• Supervises a team of inspectors in Quality Control Operation Areas.
• Analyzes trends and recommends changes to sampling plans, procedures, inspections methods or tooling.
• Recommends modifications to minimize cost and labor.
• Coordinates and participates in internal or external audits to ensure quality compliance.
• Evaluates and implements changes for efficiency and effectiveness of inspections.
• Analyzes and investigates data, reports quality problems, and follows up on corrective actions.
• Ensures compliance with ISO13485, 21 CFR 820 and related QMS requirements.
• Interfaces with R&D and engineering to determine need for process/product changes from NCRs.
• Requests and confirms corrective actions from suppliers/engineers to prevent recurrence.
• Updates Quality procedures and sampling plans as needed.
• Facilitates inspector training and ensures training is up to date.
• Manages non-conformance report generation, tracking and closure.

Skills

Analytical skills

Interacting with all levels

Computer and software skills

Motivate others / improve efficiency

Knowledge of sampling plans

Education

BS in Engineering

Job description

Terumo Aortic is seeking a Quality Operations supervisor to lead inspectors, analyze NCRs, and ensure compliance with ISO 13485 and 21 CFR 820. The role involves coordinating audits, driving process improvements, and collaborating with R&D to implement corrective actions.

The position demands a BS in Engineering or equivalent medical device quality experience, strong analytical abilities, and the ability to motivate teams while improving efficiency.